HealthAnalytix, LLC, 85 Larch St., Providence, RI, USA.
CollaborateUp Inc, 208 Noland Street, Falls Church, VA, USA.
Trials. 2023 Mar 2;24(1):158. doi: 10.1186/s13063-023-07185-4.
Clinical trial participants have a right to be informed throughout the entire process of human subject research. As part of this pillar of research ethics, participants and other stakeholders should be made aware of research findings after a trial has been completed. Though participants have both a right, and a desire to be informed of research outcomes, studies show that they rarely receive communication about study findings. Our aim was (1) to understand what, if any, role communication plans play in current global health clinical research protocols and (2) to use our findings to develop a communication plan template tailored to clinical research carried out in low-and-middle-income countries (LMIC) while minimizing colonial assumptions. While the template was drafted in the LMIC context, the principles are universally applicable and should be considered best practices for all global health clinical trials.
We carried out a mixed-method study over a period of 6 months to understand the role of communication with study participants and other stakeholders in clinical trials. The semiquantitative analysis included mining publicly available clinical trial protocols for communication-related language. Qualitative interviews (n = 7) were used to gather knowledge and insight from clinical trial experts to inform the development of a communication plan template.
None of the 48 mined clinical trial protocols included a communication plan. Of the 48, 21% (n = 21) protocols included communication-related language, and 10% (n = 5) described plans to share trial results with participants.
The use of communication plans in global health clinical trials is lacking. To our knowledge, this is the first in-depth analysis of communication plans in clinical trials to date. We recommend that researchers utilize the developed communication plan template throughout the entire research process to ensure a human-centered approach to participant communication. This communication plan should apply to all phases of a research trial, with a particular emphasis on plans to share results in an accessible and engaging manner once the trial has been completed.
临床试验参与者有权在人体研究的整个过程中获得信息。作为研究伦理的一个支柱，参与者和其他利益相关者应该在试验完成后了解研究结果。尽管参与者有权并且希望了解研究结果，但研究表明，他们很少收到关于研究结果的沟通。我们的目标是：（1）了解沟通计划在当前全球卫生临床研究方案中扮演的角色，如果有的话；（2）利用我们的发现，制定一个针对中低收入国家（LMIC）开展的临床研究的沟通计划模板，同时最大限度地减少殖民主义假设。虽然模板是在 LMIC 背景下起草的，但这些原则具有普遍性，应该被视为所有全球卫生临床试验的最佳实践。
我们进行了一项为期 6 个月的混合方法研究，以了解与研究参与者和其他利益相关者沟通在临床试验中的作用。半定量分析包括挖掘公开可用的临床试验方案中与沟通相关的语言。定性访谈（n=7）用于从临床试验专家那里收集知识和见解，为沟通计划模板的制定提供信息。
在挖掘的 48 项临床试验方案中，没有一项包括沟通计划。在这 48 项方案中，有 21%（n=21）的方案包括与沟通相关的语言，有 10%（n=5）的方案描述了与参与者分享试验结果的计划。
全球卫生临床试验中沟通计划的使用不足。据我们所知，这是迄今为止对临床试验中沟通计划的首次深入分析。我们建议研究人员在整个研究过程中使用开发的沟通计划模板，以确保以参与者为中心的沟通方法。该沟通计划应适用于研究试验的所有阶段，特别强调在试验完成后以可访问和引人入胜的方式分享结果的计划。
